- Management of CAPA from tracking, including follow-ups and closure.
- Management of Change Control, Deviations, from tracking, follow-ups and closure.
- Review quality process control plan, drive quality issues to root cause, corrective actions and improvements.
- Perform, document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP inspection.
- Coordinate and assists during customer visits and audits.
- Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
- Review the implementation and efficiency of quality and inspection systems.
- Collect, compile statistical quality data, and analyze data to identify areas for improvement in the quality system.
- Review of analytical reports, and batch records (manufacturing and packaging).
- Perform SAP QM setting, review test results, block / unblock of finished products.
- Manage customer queries, customer satisfaction surveys, and questionnaires and other quality / regulatory purpose documentation requests.
- Investigate customer complaints and non-conformance issues.
- Consolidate data to create the annual product quality review report.
- Track quality performance and initiate quality improvement plans.
- Perform risk assessments and monitor risk management activities at quality level.
- Conduct / perform training to employees to improve GMP / international standards certification awareness and compliance.
- Perform any other duties and responsibilities as assigned from time to time.
- Comprehensive knowledge in GMP and Food Safety Management System (HACCP) and knowledge in ISO 22000 certification, Quality compliance.
- Experience in batch release for API, QMS/FSMS Management, internal audit, validation activities, training management, Deviation/CAPA/Change Control, OOS.
Requirements:
- Comprehensive knowledge in GMP and Food Safety Management System (HACCP (Hazard Analysis and Critical Control Points) and knowledge in ISO 22000 certification, Quality compliance.
- At least 3 years of working experienced as Quality Assurance with thorough experience in batch release for API, QMS/FSMS Management, internal audit, validation activities, training management.
- Comprehensive knowledge on topics related to Quality such as Deviation/CAPA/Change Control, OOS.
Interested candidates, please send your detailed resume stating Past Employments, including Reasons of Leaving, Last Drawn Salary for the most recent 2 positions (breakdown of basic salary, allowance, bonuses etc), Expected Basic Salary and availability to my email : [Confidential Information]
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Manfield Employment Services Pte Ltd (Lic. No: 95C2823)
Posting Personnel: Quennie Chen
EA Personnel Reg No.: R1222837
